National Gene Vector Biorepository Will Begin Storing Human Clinical Samples

After 15 years of supporting gene therapy research, the National Gene Vector Biorepository (NGVB) will expand its archiving services this year to include human clinical samples. 

“The expansion will help investigators meet FDA requirements to follow gene therapy patients for long periods of time,” says ASGCT Member Kenneth Cornetta, MD, a professor at the Indiana University School of Medicine where the NGVB is based, and the organization’s principal investigator.  

Most of NGVB’s services are provided at no cost to eligible National Heart, Lung, and Blood Institute (NHLBI)-funded investigators. The NGVB has provided more than 1,000 reagents to gene therapy investigators since it began operating in May 2008. It has a repository of more than 80 reagents, including AAV and lentiviral vector plasmids and different types of cell lines.  

NGVB also offers sample archiving and testing services to investigators funded by NHLBI, its primary supporter. Cornetta says archiving provides a way for investigators to continue to store materials long after initial grant funding has expired. NIH investigators performing preclinical animal pharmacology and toxicology studies can store their samples under Good Laboratory Practice conditions that meet FDA storage requirements. Currently, NGVB is storing more than 29,000 samples including DNA, tissue, and pathology biospecimens. 

NGVB also offers testing to help investigators meet FDA requirements for clinical gene therapy under Good Manufacturing Practices. Since FDA requires testing for potential insertional oncogenesis in certain clinical trials, NGVB offers amplification of vector insertion sites, next-gen sequencing, and bioinformatics analysis. 

All samples stored in NGVB remain the property of the submitting investigator, Cornetta says. 

Visit NGVB’s website to learn about its services, publications, and more.